DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 17-36 are pending; claims 17-22 and 34-36 are examined, claims 23-33 are withdrawn pursuant to election without traverse on 06/17/2025.
Applicant’s arguments, filed 12/16/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 17-22 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (CN 108794418A, 11/13/2018, IDS reference) (hereinafter Huang).
Huang discloses a co-amorphous substance of valsartan and nicotinamide in a molar ratio of 1:1, dissolved in organic solvent including ethanol (claim 4), which exhibits significantly improved solubility in water compared with valsartan bulk drug and physical mixture (last ¶). The co-amorphous substance of valsartan and nicotinamide may be prepared by dissolving valsartan in the organic solvent, adding nicotinamide, stirring and dissolving to obtain a clear solution, evaporating the solvent in a fume hood, and vacuum drying (claim 2).
As noted by p. 11, lines 13-17 of the instant Specification, nicotinamide is a low molecular weight co-former capable of forming hydrogen bonds with valsartan molecules. As noted by p. 1, lines 36-37 of the Specification, a low molecular weight co-former has a molecular weight below 900 g/mol. Thus Huang discloses a co-amorphous solid dispersion of valsartan, nicotinamide (i.e., instantly claimed co-former capable of forming hydrogen bonds with valsartan molecules of claim 21), and ethanol (i.e. instantly claimed at least one non-toxic amphiphilic solvent that solvates valsartan and co-former molecules of claims 22 and 36).
Regarding the claims reciting wherein the solid dispersion is solvated, Huang does not explicitly disclose wherein the co-amorphous substance is solvated. However, since the substance of Huang is co-amorphous and comprises substantially the same components (i.e. valsartan, nicotinamide, and ethanol), one of ordinary skill in the art would reasonably conclude that the co-amorphous substance to be solvated like the claimed invention. See MPEP § 2112.
Regarding claims 18 and 19, Huang differs from the instant claims insofar as not explicitly disclosing the amount of valsartan in mol %. However, Huang does exemplify a molar ratio of valsartan and nicotinamide to be 1:1 (i.e. equimolar), and using that as a starting point, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed ranges of valsartan in mol% (i.e. exceeds 40 mol%, exceeds 45 mol %, or ranges from 46 to 49 mol %) through routine experimentation based on the level of therapeutic effect desired. See MPEP § 2144.05(II)(A).
Similarly, regarding claims 22 and 34-35, although Huang does not explicitly disclose the amount of ethanol in the co-amorphous solid dispersion, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed amount of solvent (i.e., more than 2 mol %, or more than 5 mol %, respectively) through routine experimentation based on the evaporation and drying time desired. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claim 20, as discussed above, Huang discloses wherein nicotinamide improves the solubility of valsartan. Accordingly, nicotinamide meets the claimed limitation of supporting the effect of valsartan by improving its solubility and thus its availability.
Regarding claim 21, as discussed above, Huang exemplifies a molar ratio of valsartan and nicotinamide to be 1:1 (i.e. equimolar).
Response to Arguments
Applicant's arguments filed 16 December 2025 have been fully considered but they are not persuasive. Applicant’s arguments are mainly based on the process of producing the claimed product, which are not recited in the claims. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., mixing and homogenization in condensed-phase, mechanochemical grinding treatment, and stirring at a specific temperature range followed by stripping off excess solvent at a specific temperature range) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant mainly asserts on pp. 9-11 that Huang critically fails to disclose or suggest the formation of a solvated co-amorphous dispersion and retaining the amphiphilic solvent as required by the instant claims. Applicant further asserts that the PXRD patterns of the instant claims confirm the amorphous nature of the solvated dispersions, showing broad halos rather than sharp crystalline peaks, and that Huang employs dissolution in large quantities of ethanol followed by complete evaporation and vacuum drying (see § 5.A).
The examiner does not find the argument persuasive. Huang does not explicitly disclose wherein the solvent must be completely evaporated. Moreover, Huang discloses wherein the powder X ray diffraction of the co-amorphous substance shows no sharp diffraction peaks (§1), and a glass transition temperature of 51.2 °C (§2). Example 1 (p. 12) of the instant Specification discusses similar lack of sharp diffraction peaks, and a glass transition temperature of 50.8 °C (p.12, lines 25 and 35). Therefore it would reasonably appear that the co-amorphous substance of Huang comprises substantially the same solvated co-amorphous solid dispersion as the claimed invention.
Applicant mainly asserts on pp. 11-12 that one of ordinary skill in the art would not be motivated to modify Huang to form a solvate, and that Huang uses dissolution with large volumes of solvent followed by complete desolvation to create a binary co-amorphous system (see § 5.B). Applicant further asserts on p. 12 that Huang teaches away from the claimed invention by consistently emphasizing complete solvent removal through both evaporation in a fume hood and subsequent vacuum drying at 25 °C for 6-8 hours in all 4 examples (See § 5.C).
The examiner does not find the assertion persuasive. Applicant’s argument appears to be based on the assertion that Huang completely evaporates the solvent. Although Huang does not explicitly disclose wherein a portion of the solvent is retained, it is not necessary for Huang to explicitly teach all the claim limitations. "Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art. The prior art reference (or references when combined) need not teach or suggest all the claim limitations." See MPEP 2141 (III). In this instant case, since Huang is able to produce a co-amorphous substance (i.e. no crystallization or single amorphous state precipitation), and comprises substantially the same components (i.e. valsartan, nicotinamide, and ethanol), one of ordinary skill in the art would reasonably conclude the co-amorphous substance to be solvated like the claimed invention. See MPEP § 2112. Moreover, Huang does not teach away as it does not explicitly disclose wherein the solvent must be completely evaporated. "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." MPEP 2123(II). As such, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.
Applicant mainly asserts on pp. 12-13 that the claimed solvated co-amorphous dispersion unexpectedly achieves greater solubility compared to the starting valsartan used for preparation (See § 5.D).
The examiner is not persuaded by this argument. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Specifically, regarding the allegations of unexpected results, Applicant has the burden of explaining the data in any declaration they proffer as evidence of non-obviousness. See MPEP § 716.02(b)(II). Applicant has explained that various statements referenced in the specification support their position, but these cannot take the place of evidence in the record. See MPEP § 716.01(c)(II). Finally, assuming purely arguendo that the unexpectedness of the results have been established, the probative value of the evidence as compared to the invention as claimed must then be determined, i.e. the claims must be “commensurate in scope” with the showing. MPEP § 7`6.02(d). See also MPEP § 2145. According to p. 11, lines 24-41 of the instant Specification, even if Applicant were to show unexpected results, they would have been obtained, for example, with a combination of many independent factors, including specific co-former (e.g. nicotinamide), the use of a certain amount of specific amphiphilic solvent (e.g. ethanol, n-propanol, or i-propanol), and high temperature homogenization or high temperature stripping off the excess solvent, leading to specific amounts of retention of the amphiphilic solvent. It is not clear to the examiner how the instant claims are reasonably representative (i.e. commensurate in scope) with the alleged unexpected results, which utilizes specific amounts of specific species of amphiphilic solvent and co-former and achieves a specific rate of amphiphilic solvent retention.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/ Supervisory Primary Examiner, Art Unit 1612